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Sign in to claim this brandBIOMERIEUX SA
France·FR-MF-000004436
Last updated May 25, 2026
Information
- Country
- France
- Address
- 376, Chemin de l'Orme, Marcy-l'Étoile, France
- Website
- biomerieux.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Pierre CHARBONNIER
- EUDAMED SRN
- FR-MF-000004436
- FDA FEI Number
- —
- DUNS Number
- 276816717
Catalogue (140)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VIDAS® DENGUE NS1 Ag | 423077 | EUDAMED | Class C | Active |
| SMAC CT Agar | 542126 | EUDAMED | Class A | Active |
| Mycoplasma | 42507 | EUDAMED | Class A | Active |
| VIDAS® Prolactin | 30410 | EUDAMED | Class B | Active |
| Lyophilized rabbit plasma | 540602 | EUDAMED | Class A | Active |
| Color Gram 2 (COLOR GRAM 2 - F) | 55542 | EUDAMED | Class A | Active |
| ETEST® MBL Meropenem/Meropenem + EDTA (MP/MPI) | 543045 | EUDAMED | Class B | Active |
| ETEST® Isavuconazole (ISA) | 543180 | EUDAMED | Class B | Active |
| Rappaport broth | 42091 | EUDAMED | Class A | Active |
| Mueller Hinton E Agar | 541963 | EUDAMED | Class B | Active |
| ETEST® Mecillinam (MM) | 543055 | EUDAMED | Class B | Active |
| VIDAS® TOXO IgM | 30202 | EUDAMED | Class C | Active |
| Schaedler Broth with 0.02% Agar + vit. K3 | 42097 | EUDAMED | Class A | Active |
| ETEST® ESBL Cefepime/cefepime + clavulanic acid (PM/PML) | 543022 | EUDAMED | Class B | Active |
| Schaedler Broth with 0.2% Agar + vit. K3 | 42098 | EUDAMED | Class A | Active |
| Trypcase Soy Agar | 542080 | EUDAMED | Class A | Active |
| Previ® Color Gram Rc Crystal Violet Solution | 29524 | EUDAMED | Class A | Active |
| VIDAS® Anti-CHIKUNGUNYA IgG | 423230 | EUDAMED | Class B | Active |
| ETEST® Kanamycin (KM) | 8308997 | EUDAMED | Class B | Active |
| VIDAS® Anti-TPO | 30461 | EUDAMED | Class B | Active |
| Mannitol Salt 2 Agar | 542182 | EUDAMED | Class A | Active |
| SS agar | 51043 | EUDAMED | Class A | Active |
| ETEST® Nalidixic-acid (NA) | 543047 | EUDAMED | Class B | Active |
| Vidas® Pth (1-84) | 422010 | EUDAMED | Class B | Active |
| Uriline (URILINE) | 543299 | EUDAMED | Class A | Active |
| VIDAS® Anti-CHIKUNGUNYA IgM | 423229-30 | EUDAMED | Class B | Active |
| ETEST® Cefepime Taniborbactam (FTB) | 543253 | EUDAMED | Class B | Active |
| BCSA Agar | 541852 | EUDAMED | Class A | Active |
| Vidas® Tb-Igra | 423111 | EUDAMED | Class C | Active |
| Urea indole medium (UI-F) | 55752 | EUDAMED | Class A | Active |
| ETEST® Posaconazole (POS) | 543310 | EUDAMED | Class B | Active |
| ETEST® Voriconazole (VO) | 542781 | EUDAMED | Class B | Active |
| Sabouraud 2 agar | 51020 | EUDAMED | Class A | Active |
| PORTAGERM™ bottles | 542005 | EUDAMED | Class A | Active |
| VIDAS® EBV EBNA IgG | 30235 | EUDAMED | Class B | Active |
| VIDAS® Anti-HEV IgM | 418115 | EUDAMED | Class C | Active |
| Parvovirus B19 R-GENE® | 69-019B | EUDAMED | Class C | Active |
| Color Gram 2 (COLOR GRAM 2 R4 - F) | 55548 | EUDAMED | Class A | Active |
| ETEST® Teicoplanin (TP) | 542772 | EUDAMED | Class B | Active |
| ETEST® MBL Imipenem/Imipenem + EDTA (IP/IPI) | 543032 | EUDAMED | Class B | Active |
| Pylori Agar | 541952 | EUDAMED | Class A | Active |
| Uriline 3 Enterococcus (URILINE 3 ENTEROCOCCUS) | 56526 | EUDAMED | Class A | Active |
| Oxidase Reagent | 55635 | EUDAMED | Class A | Active |
| Enterovirus R-Gene® | 69-005B | EUDAMED | Class C | Active |
| VIDAS® High sensitive Troponin I | 415386 | EUDAMED | Class C | Active |
| Schaedler Neo. Vanco. agar + 5% sheep blood | 541955 | EUDAMED | Class A | Active |
| Urée-Arginine LYO 2 | 42508 | EUDAMED | Class A | Active |
| VIDAS® Anti-CHIKUNGUNYA IgM | 423229 | EUDAMED | Class B | Active |
| Hsv1 Hsv2 R-Gene® | 71-021 | EUDAMED | Class C | Active |
| VIDAS® Anti-Tg | 30462 | EUDAMED | Class B | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 5, 2026 | Z-1236-2026 | — | open, classified | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results. |
| Jun 26, 2025 | Z-2671-2025 | — | open, classified | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards |
| Mar 14, 2024 | Z-1464-2024 | — | open, classified | Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2. |
| Feb 6, 2023 | Z-1201-2023 | — | open, classified | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician. |
| Nov 9, 2022 | Z-0787-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0865-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0834-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0796-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0807-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0833-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0803-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0853-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0856-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0875-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0869-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0836-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0872-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0857-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0860-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0814-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0823-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0827-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0847-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0824-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0798-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0870-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0874-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0868-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0837-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0844-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0850-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0813-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0809-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0786-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0826-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0808-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0800-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0785-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0810-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0866-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0867-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0783-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0848-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0830-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0790-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0799-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0832-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0852-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0839-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0812-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0843-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0840-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0792-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0788-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0802-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0791-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0817-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0816-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0806-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0873-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0805-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0825-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0842-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0845-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0829-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0789-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0815-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0797-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0861-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0862-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0854-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0819-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0849-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0846-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0835-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0855-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0858-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0851-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0828-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0801-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0859-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0795-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0876-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0821-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0820-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0863-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0793-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0871-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0818-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0822-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0841-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0794-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0804-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0864-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0831-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0784-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0811-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Z-0838-2023 | — | open, classified | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Jul 20, 2022 | Z-1564-2022 | — | open, classified | There is a potential of no result leading to possible delayed result due to contamination of extraction reagents. |
| Jul 13, 2022 | Z-1640-2022 | — | open, classified | There are 7 reported software anomalies that may affect use of the device. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Biomérieux US